Fentanyl Transdermal Patch With CHADD™ for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Pain

• Patient's rating of pain intensity (NRS), the patient's evaluation of pain relief using a 5-point verbal rating scale (VRS), and the patient's global satisfaction assessment. [ Time Frame: 0, 15, 20, 60 minutes ] [ Designated as safety issue: No ]
  Efficacy will be evaluated by the patient's rating of pain intensity using an 11-point numerical rating scale (NRS), the patient's evaluation of pain relief using a 5-point verbal rating scale (VRS), and the patient's global satisfaction assessment.
  
  

• Adhesion assessment [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
  An adhesion assessment will be conducted by the patient at each CHADD removal.
  
  
• Pain Relief [ Time Frame: 15, 30, 60 minutes ] [ Designated as safety issue: No ]
  Patient's evaluation of pain relief using a 5-point verbal rating scale (VRS)
  
  
• Patient's Global Satisfaction Assessment [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

  Patients completed a global satisfaction assessment 60 minutes after CHADD application. Patients were asked to assess their overall satisfaction with the CHADD throughout the 60 minute application period for the treatment of their breakthrough pain using the following 5-point scale: 0=not satisfied,

  1=somewhat satisfied, 2=moderately satisfied, 3=very satisfied, and 4=completely satisfied.

  
  
• Number of participants with adverse events [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
  The frequency of adverse events, severity, and relationship to study drug was recorded.
  
  

ZARS Pharma is developing a Matrix Transdermal Fentanyl/CHADD (Controlled Heat-Assisted Drug Delivery) Drug Delivery System to be used for the treatment of chronic and breakthrough pain. The Matrix Transdermal Fentanyl/CHADD Drug Delivery System has been designed to provide long-term delivery of fentanyl for the treatment of chronic pain as well as intermittent increases in fentanyl concentrations for the treatment of breakthrough pain. Breakthrough pain is defined as a transitory exacerbation of pain that occurs on a background of otherwise stable pain in a patient receiving chronic opioid therapy.

Matrix Transdermal Fentanyl/CHADD Drug Delivery System has 2 components: a matrix transdermal fentanyl patch (the ZR-02-01 patch in doses of 25, 50, 75 and 100 mcg/hr) with corresponding thin film dressing (ie, overlay) and the CHADD (Controlled Heat-Assisted Drug Delivery).

The matrix transdermal fentanyl patch provides a continuous delivery of fentanyl over 72 hours, in a manner similar to Duragesic®. During a breakthrough pain episode, a CHADD unit is placed over (adhered to) the matrix transdermal fentanyl patch. The CHADD is a thin patch-like chemical heating device that generates a controlled level of heat for approximately 15-20 minutes. The application of heat delivers increased amounts of fentanyl when applied over the ZR-02-01 matrix transdermal fentanyl patch.